Registration Dossier
Registration Dossier
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EC number: 306-832-3 | CAS number: 97416-84-7
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. The summary report is taken from IPCS Environmental Health Criteria 172 (WHO), which is a relayble internationally accepted sorce. The justification for the Read Across approach has been attached to the Section 13
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Tetrabromobisphenol A and Derivatived (Environmental health criteria ; 172).
- Author:
- G.J. van Esch
- Year:
- 1 995
- Bibliographic source:
- World Health Organization; IPCS
- Reference Type:
- other: Secondary Source
- Title:
- Unscheduled DNA synthesis rat hepatocyte assay, GLCC 785-104C
- Author:
- Cavagnaro J & Sernau RC
- Year:
- 1 984
- Bibliographic source:
- Vienna, Virginia, Hazleton Biotechnologies Corporation
Materials and methods
- Principles of method if other than guideline:
- No available information on method used.
- GLP compliance:
- not specified
- Type of assay:
- unscheduled DNA synthesis
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- other: No data available
- Vehicle:
- DMSO
- Details on exposure:
- No data available
- Duration of treatment / exposure:
- No data available
- Frequency of treatment:
- No data available
- Post exposure period:
- No data available
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
10 µg/l
Basis:
no data
- Remarks:
- Doses / Concentrations:
50 µg/l
Basis:
no data
- Remarks:
- Doses / Concentrations:
100 µg/l
Basis:
no data
- Remarks:
- Doses / Concentrations:
500 µg/l
Basis:
no data
- Remarks:
- Doses / Concentrations:
1000 µg/l
Basis:
no data
- No. of animals per sex per dose:
- No data available
- Control animals:
- yes
- Positive control(s):
- Positive medium and solvent controls
Examinations
- Tissues and cell types examined:
- No data available
- Details of tissue and slide preparation:
- No data available
- Evaluation criteria:
- No data available
- Statistics:
- No data available
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Not mutagenic - Executive summary:
References
The evaluation of Genetic toxicity reported from (Cavagnaro & Sernau, 1984) [1] in the WHO publication[2] has been considered in order to complete the assessment.
Method and observations
The substance was tested in rats (Sprague-Dawley) by means of unscheduled DNA Synthesis Assay in duplicate doses of 10, 50, 100, 500, and 1000 µg/ml. The high dose was selected on the basis of the solubility of the substance in DMSO. Positive medium and solvent controls confirmed the sensitivity of the system
Results
No significant increase in the mean nuclear grain count was observed at any dose level compared with the solvent control.
[1] Cavagnaro J & Sernau RC (1984) Unscheduled DNA synthesis rat hepatocyte assay, GLCC 785-104C. (Final report). Vienna, Virginia, Hazleton Biotechnologies Corporation (Report to Great Lakes Chemical Corporation, West Lafayette, submitted to WHO by the Brominated Flame Retardant Industry Panel).
[2]World Health Organization (WHO, Geneva, 1995); Dr. G.J. van Esch “Tetrabromobisphenol A and Derivatived” (Environmental health criteria; 172)
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